Oncology Biosimilar Roundup for January 2021

During January 2021, The Center for Biosimilars® published findings from multiple studies that demonstrated the potential of biosimilars in the oncology space. Some of these results were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) and the ASCO Gastrointestinal Cancers Symposium 2021 (ASCO GI). Also, the FDA initiated a review of a bevacizumab biosimilar candidate.

Bevacizumab Potential

The FDA accepted a biologics license application for the review of Bio-Thera Solutions’ bevacizumab biosimilar candidate, BAT1706. The proposed biosimilar could become the third bevacizumab biosimilar to enter the US market, following Mvasi and Zirabev, which launched in July 2019 and January 2020, respectively, and together have achieved a 40% share of the US bevacizumab market.

Bio-Thera Solutions of Guangzhou, China, is seeking indications for metastatic colorectal cancer (mCRC), non–small cell lung cancer (NSCLC), glioblastoma, metastatic renal cell carcinoma, and metastatic cervical cancer. The company has also filed for regulatory approval in China and the European Union.

Additionally, a review evaluating the “totality of evidence” for Mvasi, an Amgen product, found no clinically meaningful differences between the biosimilar and the reference product, Genentech’s Avastin. The reviewers also concluded that historical data support extrapolation to all of Avastin’s indications. Mvasi is currently approved to treat mCRC, metastatic cervical cancer, and NSCLC.

Breast Cancer

During January, we reported more presentations from SABCS. One of studies we covered found strong uptake in Europe for the trastuzumab biosimilar Kanjinti among patients with metastatic breast cancer.

In the study, 28% of the sites analyzed had policies on biosimilar use and 36% of patients were informed they were being started on a biosimilar; of those, 34% were aware of what brand of biosimilar would be administered. Investigators said 40% of the patients switched to Kanjinti from another trastuzumab product, 44% switched from the intravenous form of the reference product, and 15% switched from the subcutaneous form.

Another study from SABCS confirmed the biosimilarity of Viatris’ trastuzumab biosimilar Ogivri to the reference product. The data came from the HERITAGE randomized phase 3 trial, which previously demonstrated comparable efficacy and safety profiles between Ogivri and the originator, Herceptin, as frontline treatment for women with human epidermal growth factor receptor 2 positive advanced breast cancer. Ogivri launched on the US market in December 2019.

Colorectal and Gastrointestinal Cancers

A retrospective study presented at ASCO GI demonstrated that initial uptake of Mvasi in the United States was strongest among patients with mCRC. Investigators also concluded that providers were comfortable initiating bevacizumab biosimilar treatment or switching patients to Mvasi. Patient characteristics and demographics were not significantly different between those switched from the reference product and those who initiated treatment with the biosimilar.

A separate study of Mvasi at ASCO GI demonstrated that physicians are comfortable prescribing the biosimilar for patients with mCRC in accord with historical use of reverence bevacizumab. Evidence showed that the patient cohort that received first-line biosimilar treatment was similar in terms of demographics and clinical characteristics to the reference product cohort.

A third study at ASCO GI had inconclusive results on the incidence of hypertension and proteinuria in patients with gastrointestinal cancer treated with reference bevacizumab as opposed to biosimilars (Mvasi, Zirabev). A higher risk of hypertension was observed for the reference product cohort, but this was not statistically significant (P = .2427). Additionally, hypertension was observed in patients after a median of 5 doses of the reference product vs 1.5 doses of bevacizumab biosimilar (P = .0005).